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P522 Effectiveness of tofacitinib in a real-world Israeli cohort of patients with moderate-severe ulcerative colitis

Avni Biron, I.(1);Bar-Gil Shitrit , A.(2);Koslowsky, B.(2);Kopylov, U.(3);Levartovsky, A.(3);Weisshof, R.(4);Aviv-Cohen, N.(5);Maharshak, N.(5);Hovel, D.(6);Naftali, T.(7);Goren, I.(1);Snir, I.(1);ollech, J.(1);Banai, H.(1);Lena, B.(1);Dotan, I.(1);Yanai, H.(1);

(1)Rabin Medical Center - Beilinson Hospital, Department of Gastroenterology, Petah Tikva, Israel;(2)Shaare Zedek Medical Center, Digestive Diseases Institute, Jerusalem, Israel;(3)Sheba Medical Center, Department of Gastroenterology and Liver Diseases, Ramat-Gan, Israel;(4)Rambam Health Care Campus, Gastroenterology Institute, Haifa, Israel;(5)Tel Aviv Medical Center, IBD Center- Department of Gastroenterology and Liver Diseases, Tel-Aviv, Israel;(6)Edith Wolfson Medical Center, Department of Gastroenterology and Liver Diseases, Holon, Israel;(7)Meir Medical Center, Department of Gastroenterology and Liver Diseases, Kfar-sava, Israel

Background

We sought to define the effectiveness of tofacitinib in a real-world (RW) cohort of patients with moderate to severe ulcerative colitis (UC).

 

Methods

This was a multi-center retrospective observational cohort study (2017-2020). Clinical response and remission were defined as a reduction in Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) of ≥3, and SCCAI ≤2 or a PMS ≤1, respectively.

 

Results

We included 73 patients (47% male; median age 26 years [IQR 19.5-39.5], disease duration 7 years [IQR 2.5-14.5], follow-up 7.1 months [IQR 3-12]), 91% biologics-experienced, and 74% ≥ 2-biologics. Half of patients used concomitant steroids. Overall, 56.1% discontinued therapy due to either lack of response and/or adverse events (AEs), median time to discontinuation - 9.7 months (IQR 3.4-16). Based on per-protocol analysis, after induction (week-8-16), 33.3% achieved response, 23.3% remission, and 19% corticosteroid free remission. At early maintenance (week 26), 50% achieved response, 26.8% remission, and 24.4% corticosteroid free remission. There were no differences between biologics-experienced and naïve patients. Seventeen patients (23.2%) had an AE: herpes zoster- 2.7%, hospitalization- 12.3%, and colectomy- 2.7%. Remitters had higher albumin level compared with non-remitters (4.2±0.35 Vs. 3.8±0.35, P=0.023, respectively).

Conclusion

In this multicenter RW cohort of highly biologics - experienced patients with UC, those who continued tofacitinib throughout induction achieved 50% response and 27% remission. Tofacitinib was well-tolerated.

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